Myofascial pain syndrome Trials in Disease

Study on Pain Relief for Fibromyalgia Patients with Trapezius Myofascial Syndrome Using Bupivacaine, Triamcinolone, and Sodium Chloride

This clinical trial is investigating treatment options for patients who have fibromyalgia combined with trapezius myofascial pain syndrome. The trapezius is a large muscle that extends over the back of the neck and shoulders, and when it develops trigger points and tight bands, it can cause significant pain and discomfort.

Main inclusion criteria:

• Participants must be over 18 years old
• Must have a confirmed diagnosis of fibromyalgia based on established criteria
• Must experience continuous pain in the upper trapezius area for more than three months, with the pain rated above 3 on both local and general pain scales
• Should have noticeable trigger points and tight muscle bands in the trapezius
• Treatment history should be stable for at least three months, with use of weak pain relievers like tramadol, codeine, paracetamol, or metamizol
• Must provide informed consent to participate

Main exclusion criteria:

• Patients without confirmed fibromyalgia and trapezius myofascial syndrome
• Those unable to provide informed consent or understand study requirements
• Patients with allergies to the study medications, including bupivacaine or triamcinolone
• Pregnant or breastfeeding women
• Those currently participating in another clinical trial
• Patients with other medical conditions that might interfere with study results
• Individuals with a history of substance abuse or severe mental health conditions
• Those who have had recent surgery or are planning surgery during the study period

Focus and goal of the trial:

The study aims to compare the effectiveness of different injection-based treatments in reducing pain for patients with both fibromyalgia and trapezius muscle pain. The treatments are delivered using ultrasound guidance to ensure accuracy, targeting specific areas between muscles in the shoulder region. Researchers will monitor participants over several weeks to assess changes in pain levels, including both localized trapezius pain and overall body pain. Additional measures include evaluating fatigue, sleep quality, functional capacity, quality of life, and levels of anxiety or depression. Follow-up assessments are scheduled at weeks 2, 4, and 12 to track the duration and effectiveness of pain relief.

Investigational treatments:

The trial is testing three different substances:

• Bupivacaine – a local anesthetic that numbs the treatment area by blocking nerve signals that carry pain messages to the brain
• Triamcinolone – a corticosteroid medication that reduces inflammation and pain by suppressing the immune response in the affected area
• Physiological saline – a simple saltwater solution used as a control treatment to compare against the active medications

All treatments are administered through intramuscular injections guided by ultrasound imaging. The study also uses lidocaine hydrochloride alongside these treatments. By comparing the effects of these different approaches, researchers hope to identify which treatment provides the most effective and longest-lasting pain relief for this patient population.